Chemotherapy-induced nausea and vomiting (CINV) associated with the administration of moderately or highly emetogenic multi-day chemotherapy.
Conditions
Interventions
Product Name: Granisetron transdermal delivery system
Product Code: GTDS
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Granisetron
CAS Number: 109889-09-0
Concentration unit: mg milligra
Sponsors
Strakan Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female aged =18yrs (no upper limit) Woman not of childbearing potential, i.e: • A surgically sterilised (tubal ligation and/or hysterectomy) female patient • A post-menopausal female patient (amenorrhoea for at least one year prior to Screening Visit) Woman of childbearing potential, i.e: • A female patient using a highly effective method of birth control (e.g., intrauterine contraceptive device; combined oral contraceptives; contraceptive implant; contraceptive skin patch or cervical ring) for 30 days prior to the start of the study, and agree to continue such precautions for one month after study completion. • A female patient with a surgically sterilised male partner (vasectomy) Female patients must have a negative pregnancy test at the Screening Visit. Histologically and/or cytologically confirmed cancer with Eastern Cooperative Oncology Group (ECOG) =2 Life expectancy of =3 months Assigned to receive the first cycle of a new multi-day chemotherapy regimen including the daily administration of cytotoxic agent(s) with the emetogenic potential of level 3-5 (Hesketh Classification) on 3-5 days Patients able to read and write at a competent level to understand the study procedures and capable of giving legal consent. Patients having provided written informed consent The study will aim to select countries and centres to ensure that a representative patient population with regard to ethnic and racial background will be included in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The presence of any of the following criteria constitutes a cause for the exclusion of the patient from the study: Previous History • Hypersensitivity to adhesive plasters • Contraindications to 5-HT3 receptor antagonists • Patients who have already been included in a clinical study with the GTDS • Any other relevant medical history at the discretion of the Investigator Concomitant Medical Condition • Current alcohol, drug or medication abuse • Breast feeding women • Clinically relevant abnormal laboratory values at the discretion of the Investigator • Clinically relevant hepatic, renal, infectious, neurological or psychiatric disorders or any other major systemic illness at the discretion of the Investigator • Any cause for nausea and vomiting other than CINV • Any episode of retching, vomiting or uncontrolled nausea within 72 h prior to the administration of the chemotherapy • Clinically relevant ECG parameters at the discretion of the Investigator and/or QTc > 450ms for male patients and QTc > 470ms for female patients • Mental conditions rendering the patient unable to understand the nature, scope and possible consequences of the study Concomitant Therapy/Medication • Concomitant radiotherapy of total body, brain or upper abdomen within one week of study entry or planned during the study • A patient taking a medication to control the symptoms of a brain tumour, brain metastasis or seizure disorder • Patients using SSRI antidepressants (unless they are on a stable dose for the duration of the study) • Receipt of any other investigational drug <30 days before the study or during the study • Scheduled to receive a NK1 receptor antagonists, dopamine receptor antagonist or another 5-HT3 receptor antagonist between 72 h prior to the administration of the chemotherapy and patch removal (Visit 6) • Drugs known to increase the QTc interval. Other • Patients unlikely to comply with the study protocol, e.g. uncooperative attitude, inability to return for follow-up visits and unlikelihood of completing the study In addition to these exclusion criteria, patients will be withdrawn from the study if the patch is more than 50% detached from the patient’s skin at Visit 1. At Visit 1, prior to the administration of the capsule, concomitant medication, AEs and adhesion of patch should be checked. If there are violations of eligibility criteria the patient should be withdrawn from the study, the patch is to be removed and the patient is to be offered the site’s standard of anti emetic care. If the patient’s chemotherapy is cancelled or delayed by more than one day, therefore the patch will have been applied more than 48 h before chemotherapy, the patient should be withdrawn from the study, the patch is to be removed and the patient is to be offered the site’s standard of anti emetic care.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate non-inferiority of the GTDS efficacy compared with oral granisetron efficacy with regard to complete control of CINV from the first administration until 24 h after the last administration of the moderately/highly emetogenic multi-day chemotherapy;Secondary Objective: Complete Control of CINV from 1st administration of chemotherapy until patch removal and during successive 24h intervals from 1st administration of chemotherapy until patch removal and time to treatment failure. Time to first emetic episode and number of emetic episodes. Complete Response of CINV from 1st administration until last administration of chemotherapy and from 1st administration chemotherapy until patch removal and during successive 24h intervals from 1st administration of chemotherapy until patch removal. Severity of nausea and frequency of more than mild nausea. Severity of vomiting. Rescue Medication: time to 1st administration. Patient’s satisfaction of treatment. To compare GTDS with oral granisetron with respect to safety: AEs (local tolerance issues at site of patch application will be recorded as AEs). Changes from Screening to end of treatment for vital signs, ECG, physical examination and laboratory values. To assess adhesion of GTDS over 7 day application period.;Primary end point(s): The primary efficacy endpoint is: • % of patients achieving Complete Control of CINV (CC, i.e. no vomiting and/or retching, no more than mild nausea and no rescue medication) from the first administration until 24 h after the last administration of the cytotoxic agent(s) with the moderately or highly emetogenic potential (according to Hesketh Classification) | — |
Countries
Czech Republic, Germany
Outcome results
None listed